HIBCC Industry News
Although our scope has expanded beyond the initial HIBC labeling mandate issued 30 years ago, we have continued to emphasize ‘safety first’ through the years.
As such, the Health Industry Business Communication Council has an important advocacy and educational role in today’s healthcare industry. We are proud to act as the forum through which consensus can be reached as all parties work together to ensure a safer, more efficient industry.
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European Parliament Expected to Adopt Medical Device Regulation (UDI) in April
On March 7th, 2017 the Council of the European Union approved two new medical device regulations, including a regulation similar to the US FDA’s UDI rule. The European Parliament is expected to adopt both regulations in April 2017. To view the EU press release click here. read more →
Enhancement to HIBCC’s HIN System Software
In order to expedite the processing of licensee requests for HINs, HIBCC has implemented a process to return all completed records in a partially completed work order to licensees. This system enhancement enables licensees to receive their data faster than ever. HIBCC is also encouraging licensees to consolidate work orders by sending all HIN requests.. read more →
HIN Distribution Files Available Online
A new set of HIN Distribution files, as of December 31, 2016, are now available for download. To download the periodic HIN Distribution from iHIN: Access iHIN at http://www.hibcchin.org/. Enter your username and password. Click on “Download” then “Distribution Download”. Review the HIN Data Use License Agreement and enter your Subscriber Account ID. Click next. The.. read more →
HIN Distribution Files Available Online
A new set of HIN Distribution files, as of October 17, 2016, are now available for download. To download the periodic HIN Distribution from iHIN: Access iHIN at http://www.hibcchin.org/. Enter your username and password. Click on “Download” then “Distribution Download”. Review the HIN Data Use License Agreement and enter your Subscriber Account ID. Click next… read more →
FDA extends UDI compliance date for Class II convenience kits and repackaged single-use devices
The FDA has extended the compliance date for UDI labeling and data submission requirements to September 24, 2018 for the class II devices listed below. All other class II devices are subject to the September 24, 2016 UDI compliance date. Collections of two or more different devices packaged together in which the devices in the package.. read more →
New Version of “Create a HIBC UDI & Bar Code” Utility Now Available
Version 2.6 of the “Create a HIBC UDI & Bar Code” utility is now available. Version 2.6 enables labelers to create UDIs & bar codes in accordance with HIBC Supplier Labeling Standard (SLS) 2.6. The public comment period has closed for SLS 2.6 and it will be posted on our website shortly (pending final approval)… read more →